Catalog Number

-

Brand Name

McKesson

Version/Model Number

16-413BGM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

e2eb18ec-0c62-4786-a044-80fc87e3c832

Public Version Date

August 23, 2018

Public Version Number

1

DI Record Publish Date

July 23, 2018

Package DI Number

40612479227727

Quantity per Package

12

Contains DI Package

20612479227716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case